Participant flow

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers · Source last updated 2026-02-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received 5x10e6 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG000

   title

   Phase I - TG4001 5x10e6 Pfu + Avelumab

2. description

   Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG001

   title

   Phase I - TG4001 5x10e7 Pfu + Avelumab

3. description

   Participants received 5x10e7 pfu TG4001 subcutaneously along with 10 mg/kg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG002

   title

   Phase II Part 1 - TG4001 5x10e7 Pfu + Avelumab

4. description

   Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG003

   title

   Phase II Part 2 - Cohort A - Participants Without Liver Metastases - TG4001 5x10e7 Pfu + Avelumab

5. description

   Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG004

   title

   Phase II Part 2 - Cohort A - Participants Without Liver Metastases - Avelumab

6. description

   Participants received 5x10e7 pfu TG4001 subcutaneously along with 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG005

   title

   Phase II Part 2 - Cohort B - Participants With Liver Metastases - TG4001 5x10e7 Pfu + Avelumab

7. description

   Participants received 800 mg avelumab intravenously until disease progression, unacceptable toxicity, participant withdrawal from study for any reason.

   id

   FG006

   title

   Phase II Part 2 - Cohort B - Participants With Liver Metastases - Avelumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Clinical Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      Under trial intervention

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         34

      4. group Id

         FG003

         num Subjects

         46

      5. group Id

         FG004

         num Subjects

         44

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         5

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         25

      4. group Id

         FG003

         num Subjects

         35

      5. group Id

         FG004

         num Subjects

         33

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         11

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Out of 361 screened participants, 143 were included in the trial and 142 were administered with trial interventions. 218 participants were not included (main reasons: 48.6% inclusion criterion of having histologically or cytologically documented HPV-16+ cancer, 18.8% inclusion criterion of having adequate hematological, hepatic and renal function)

recruitment Details

From 01 September 2017 through 27 March 2024, a total of 361 participants were screened. Phase Ib: 01 September 2017 until 11 April 2018 Phase II part 1: 04 October 2018 until 10 August 2020 Phase II part 2: 03 Jun 2021 until 27 March 2024

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice